BioView公司推出膀胱癌荧光原位杂交分析系统

 
一种自动扫描显微镜和图像分析系统，将用于帮助监测膀胱癌复发的患者。该套系统已经获得了美国食品与药品管理局的许可。

尤其特别的是，尿液标本使用Uysis公司的UroVysion膀胱癌复发试剂盒进行荧光原位杂交染色（FISH）之后，这种Duet系统可以用于检测、分类和计数尿液标本中的细胞。该试剂盒可以监测染色体3、7、17和9p21位点的异常。Duet系统是BioView有限公司的产品。

在此之前，Duet在造血细胞Giemsa染色、免疫组化染色、或者荧光原位杂交染色的羊膜细胞和原位杂交制备的细胞悬液，使用直接标记DNA探针检测X、Y、13、16和21染色体异常的技术，已经获得了FDA的许可。

BioView总裁兼首席执行官Opher Shapira指出：“我们的承诺是提供最先进的图像分析系统，用以帮助病理学家和细胞发生学家，通过使用我们的高级运算法则，在光学视野和荧光扫描图像之中，对感兴趣的细胞进行分类和计数。我们相信BioView提供的自动系统，联合使用形态学或者免疫组织化学染色方法，帮助实验室进行广泛的以FISH为基础的基因测试，为医务界提供重要的基因资料。”
 
FISH Scanning for Bladder Cancer
 
An automated scanning microscope and image analysis system is intended to aid the monitoring of patients for recurrence of bladder cancer. The system has been cleared by the U.S. Food and Drug Administration (FDA).

Specifically, this Duet system is for use in detecting, classifying, and counting of cells in urine specimens that are stained by fluorescence in situ hybridization (FISH) using the UroVysion bladder cancer recurrence kit of Vysis, Inc. (Downer’s Grove, IL, USA). The kit monitors chromosomal aberrations 3, 7, 17, and 9p21 locus. The Duet system is the product of BioView Ltd. (Rehovet, Israel).

The Duet was previously cleared by the FDA for hematopoietic cells stained by Giemsa stain, immunohistochemistry, or in situ hybridization (ISH) prepared from cell suspension and amniotic cells stained by FISH, using direct labeled DNA probes for chromosomes X, Y, 13, 16, and 21.

“Our commitment is to offer the most advanced image analysis systems to assist the pathologist and cytogeneticist in classifying and counting cells of interest, utilizing our advanced algorithms for both brightfield and fluorescent scanning,” noted Opher Shapira, president and CEO of BioView. “We believe that BioView offers the only automated system that enables laboratories to perform a wide range of genetic tests based on FISH technology, combined with morphology or immunohistochemical staining in order to provide important genetic data to the caregiver.”